It is absolutely remarkable how quickly the “low carb craze” has swept across the nation. It seems almost every food company and restaurant chain is jumping on the bandwagon. What is amazing is presently the U.S. Food and Drug Administration (FDA) prohibits all nutrient content claims that reference carbohydrates. As recently as 2003, FDA issued warning letters to companies citing such claims as, “LOWCARB,” “only 2 carbs” (emphasis on the word “only”), “reduced carbs,” and “50- percent less carbohydrates than regular bread.” FDA has not objected to purely informational claims, such as “7 grams of carbohydrates,” which does not imply the amount is either high or low.
In simple terms, a “nutrient content claim” is a claim “that directly or by implication characterizes the level of a nutrient in food.” Such claims can only be made when FDA—either in a regulation or by petition—has approved them. FDA has defined “low” claims (which would include words such as “little,” “few” or “small amount of”) for calories, total fat, saturated fat, cholesterol, sodium and sugar. Thus, a claim that a product is “low in fat” means the product has less than 3 grams of fat per reference amount (serving) (and per 50 grams if the reference amount is small).
In terms of carbohydrate claims, however, the FDA has not defined what constitutes a permissible nutrient content claim. In fact, at the present time, claims representing a product is “high in” or a “good source of” carbohydrates are expressly prohibited (21 CFR 101.54(a)).
This means any product being marketed with a “low in carbohydrates” or a “high in carbohydrates” claim is subject to potential FDA enforcement action.
Without FDA recognized definitions, there can be no consensus as to exactly what “low carb” or “high carb” means. Without any established definitions, each company currently marketing a product with such a claim is using its own definition of what the claim means. In other words, there is no standardization and consumers cannot rely on label claims without carefully examining the entire product label.
In addition, for an added level of confusion, companies are also making separate claims about the presence (or more accurately the lack of presence) of certain carbohydrates identified as “net carbs”—a term that also has not been defined by FDA, but is generally taken to mean “fermentable” carbs, such as starches and sugars. Part of the confusion may be due to the fact that there is still some disagreement as to exactly what a carbohydrate is. Unlike fats and proteins, which are clearly defined terms, the FDA has basically defined “total carbohydrates” as everything that is left over in a food when all other calorie sources are subtracted out. More specifically, the definition of “total carbohydrates” is the calculation “by subtraction of the crude protein, total fat, moisture and ash from the total weight of the food.” In other words, total carbohydrates are whatever is left, be it “soluble fiber,” “insoluble fiber,” “sugars,” “sugar alcohols” or “other carbohydrates” (e.g., starch). Certainly one area that will need to be addressed by FDA is whether carbohydrates from sugars should be treated the same as carbohydrates from sugar alcohols, assuming it is true that the body digests these constituents differently.
FDA has recognized the existence of the low carb craze and may be considering what appears to be a constructive step to assist the industry. On March 12, 2004, FDA released the report of its Obesity Working Group. The purpose of this group was to address the fact that 64 percent of Americans are overweight and more than 30 percent are obese. The working group’s primary recommendations were to initiate a “calories count” program and to enhance food labels to highlight calorie counts while stepping up enforcement to ensure labels are accurate. Fortunately, FDA did not ignore the issue of carbohydrates in its consideration of the nation’s weight problem.
As part of the same March 12 release, FDA issued a “Fact Sheet” for carbohydrates. The agency noted it had received petitions from industry asking it to define certain terms to characterize the level of carbohydrate in food for use in carbohydrate nutrient content claims, including “low carbohydrate,” “reduced carbohydrate” and “carbohydrate free.”
To date, there appear to be three petitions that have been filed with FDA, each requesting definitions for carbohydrate nutrient content claims. Kraft Foods filed the first petition on Dec. 1, 2003. ConAgra Foods filed the second petition on Jan. 22, 2004. The Grocery Manufacturers of American (GMA) filed the third petition on Feb. 2, 2004. The sheer length of these petitions (GMA’s is 34 pages and Kraft’s is 30 pages) demonstrates the complexities that need to be addressed. Each of the petitions requests definitions relating to carbohydrates and the claims “free,” “low,” “good source” and “excellent source.” None of the petitions make any specific requests concerning “net carb” claims, although ConAgra stated the claim would be the subject of a separate future submission.
FDA is considering the petitions and intends to initiate rulemaking proceedings for nutrient content claims for carbohydrates, the purpose of which would be to ensure these claims are consistent with other nutrient content claims and are not false or misleading. Furthermore, FDA stated it “intends to provide guidance to food manufacturers on the use of the term ‘net’ in relation to the carbohydrate content of food.”
In order to provide some idea of what proposed regulations might look like, in very simple terms, the petitions generally agree a food with less than 0.5 grams of carbohydrates would qualify as “carbohydrate free.” The Kraft and ConAgra petitions would set the upper limit for “low carbohydrate” claims at 6 grams, while GMA requests a 9 gram limit. There could also be a limitation on the amount of calories that could be derived from carbohydrates (50 percent is proposed).
Excellent source claims requested by the petitions would generally mean a minimum of 10 percent of the daily value or 30 grams— possibly with some limitation on the amount that could come from sugar. A “good source” claim would mean a minimum of 5 percent of Daily Value or 15 grams of carbohydrates—also possibly with some limitation on the amount of the carbohydrates that could be from sugars. The petitions also address such things as claims for meals and “main” dish products, as well as definitions when the serving size of a food is small.
FDA is, of course, not obligated to grant any of the requests that have been or will be made. The agency can grant or deny any part of the petitions, address them collectively or propose a regulation of its own with entirely different numbers then those suggested in the petitions. In addition, it is uncertain what position the agency may take on implied claims such as “Carb Aware,” “For the low carb life style,” “Carb Fit,” or “Carb Smart.” Some argue these implied claims should also only be permitted when the food meets the low in carbohydrate definition—whenever one is eventually finalized.
Some industry members have argued carb claims should be linked to “not a low calorie food” disclaimers when appropriate, as is presently required for “no sugar added” claims. Yet such disclaimers are not required for “low fat” claims, raising the question of why low carbohydrate claims should be treated differently.
In any event, it seems likely that FDA will issue a proposal for nutrient content carbohydrate definitions at some future date. The proposals will be published in the Federal Register and industry, as well as the general public, will have the opportunity to comment before final regulations are issued and become effective. It is impossible to predict a time frame but a minimum of at least two years—and possibly much longer, given FDA’s track record—seems likely before there are have final regulations.
In the interim, it seems unlikely that anything will stop or even slow the “low carb” freight train. And, the industry will continue to promote food for its carbohydrate content—or lack thereof—pending the promulgation of regulations by FDA.
Steven Shapiro is a partner in the New York-based law firm Ullman, Shapiro & Ullman LLP (www.usulaw.com). He has 16 years of experience in food and drug regulatory matters and regularly counsels clients in all areas of food and drug law relating to the manufacture and marketing of foods, dietary supplements, drugs, cosmetics and medical devices.